• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 23 G X .75 IN. BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON & CO., (BD) 23 G X .75 IN. BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET Back to Search Results
Catalog Number 367392
Device Problems Bent (1059); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Results: a sample is not available, however, the customer provided a photo of the affected device for evaluation. A photo inspection revealed a used device with a bent needle. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6287636. Conclusion: an absolute root cause for this incident cannot be determined. As the bent needle appears to have been detected after usage the cause of the bend is unknown. (b)(4).
 
Event Description
It was reported that the needle of a 23 g x. 75 in. Bd vacutainer® ultratouch¿ push button blood collection set with 7 in. Tubing and luer adapter was bent and the needle did not retract during use. The device was safety disposed of and there was no report of injury or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name23 G X .75 IN. BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceBLOOD COLLECTION SET
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer (Section G)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6507842
MDR Text Key73504068
Report Number1024879-2017-00047
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K153309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2018
Device Catalogue Number367392
Device Lot Number6287636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2017 Patient Sequence Number: 1
-
-